A randomized trial of amifostine and carmustine-containing chemotherapy to assess lung-protective effects.

We conducted a randomized, double blind, placebo-controlled multi-institutional trial to assess the ability of amifostine to protect patients against acute lung injury associated with cyclophosphamide/cisplatin/carmustine (BCNU) (STAMP I), a BCNU-containing high dose chemotherapy regimen used with hematopoietic cell transplantation. Amifostine was administered in a dose of 740 mg/m(2) for 2 doses preceding administration of BCNU, the presumed pulmonary-toxic component of the regimen. The trial was stopped after 79 patients were randomized and a planned interim analysis demonstrated that it was unlikely that pulmonary cytoprotection would be detected with further accrual. We conclude that amifostine, used in the dose and schedule we tested, does not reduce the incidence of acute lung injury produced by STAMP I. Further, we suggest that amifostine use with BCNU in other contexts and with clinically achievable doses is unlikely to protect the lung from BCNU-associated acute injury.